This position will be the primary technical point of contact for the API TS group with external, Contract Manufacturing Organizations (CMOs).
This is an exciting, frontline, technical role in a rapidly growing biopharmaceutical company, where we outsource 100% of our SM Active Pharmaceutical Ingredient / Drug Substance (API / DS) manufacturing activities. This key role supports new product and technology introductions, transfers, and technical oversight of commercial products within the Small Molecule Operating Unit (SMOpU) of Shire Technical Operations.
This position will be the primary technical point of contact for the API TS group with our internal, Process Development & Technical Services (PDTS) and external, Contract Manufacturing Organizations (CMOs). The primary role of this individual will be to own, understand and continuously improve the process capability and supply chain resiliency for the products. The Principal Scientist (PS) provides leadership, works independently with minimal supervision to ensure timely and effective implementation of new product introduction and process validation, product lifecycle changes and continuous process improvements. Activities include ensuring that technology transfer projects are efficiently and effectively implemented, to support goals of supply, quality and cost and to ensure compliance to all cGMP, industry regulations, company guidelines, SOPs and policies. The PS will be the execution lead and may act as the Process Owner for multiple processes. The incumbent may also serve as a Technical Team lead.
This position reports to the Senior Director, API Technical Services group. A Technical Ladder exists in SMOpU and the Scientists / Engineers have an opportunity to progress their career up to the level of Senior Director / Technical Steward.
50%: CMO Management and New Product Introduction
Responsible to provide technical support APIs and Registered Starting Materials at CMOs ensuring alignment with Supply Chain objectives.
- Develop and implement product technology strategies to ensure all API related business needs are met. Work closely with PDTS for the late stage product development to ensure seamless technology transfer to commercialization
- Optimize manufacturing processes using robust DoE and QbD principles
- Provide on-site technical support at CMOs
- Seek and Implement API improvement plans at CMOs
- Ensure optimal utilization of manufacturing capacity
- Investigate and address API process, quality and compliance issues
- Support inspections by the FDA and other government regulatory agencies
- Write and review all regulatory documents (NDAs, DMFs etc.)
- Manage product risk by understanding potential product risks/vulnerability (technology, safety, compliance etc.) and proactively plan mitigation
- Participate in technical due diligence activities related to prospective licensing candidates in order to ascertain the degree of process robustness, regulatory compliance and to identify issues that may impact the delivery of quality product in a timely and consistent manner
20%: Internal Product/Process Management of Supply Chain
- Serve as a lead or member of Product Quality Technical Teams. Participate in a cross-functional team to provide technical expertise for all API related matters
- Maintain and communicate project status and general issues to key stakeholders
- Provide technical expertise in matters related to change control, quality and regulatory issues
- Collaborate with Technical Operations Product Teams (TOPT), Procurement, External Supply Management and R&D to manufacture APIs
20%: Quality, Safety and Compliance
Support conformance with regulatory filings initiatives, global agency requirements and safety needs and provide guidance, where possible on global harmonization. This also includes providing technical guidance and knowledge on validation requirements
10%: CMO Metrics
Responsible to ensure metrics designed to achieve product and business objectives are effectively managed relative to product cost and life cycle opportunities
Education & Experience Requirements:
- Normally requires a PhD in Organic Chemistry or Chemical Engineering with 8 years or MS with 12 years or BS with 16 years industrial experience
- Hands-on experience in API process development, optimization and validation.
- Direct experience in technology transfer and in supporting API manufacturing
- Strong knowledge of synthetic organic chemistry and modern analytical methods
- Ability to evaluate potential API vendors from all aspects of process development, analytical development and manufacturing
Other Job Requirements:
Up to 25% travel, domestic and international, to support manufacturing at CMOs.